SCCA Network News, Issue 10 Spring 2011SCCA Network News - Spring 2011
In this Issue:
- Alternative Donor Program
- Paul O’Donnell, MD, PhD
- Breast Cancer Studies Accrual Periods Extended
- Multicare Regional Cancer Center
- Jasmine T. Daniels, MD
- Providence Cancer Center
- Joanie M. Hope, MD
- Adolescents & Young Adults OncologyProgram at Seattle Children’s
- Survivorship Database for Network Members
- Network Members Receive NAPBC Accreditation
Only 30 percent of bone marrow transplant patients have matched sibling donors. Half of the remaining 70 percent will find matched unrelated donors. That leaves 35 percent of patients looking for alternatives.
“For a long time, matched unrelated donors have been the alternative donors of choice,” says Dr. Paul O’Donnell, medical director of the Adult Blood and Marrow Transplant Service at Seattle Cancer Care Alliance (SCCA). “Our outcomes using such donors consistently outperform other centers. Now we are able to offer patients who can’t find a matched unrelated donor the option of transplants using a haploidentical donor or unrelated cord blood.”
SCCA’s Alternative Donor Program uses three types of alternative donors: haploidentical donors, unrelated donors with limited human leukocyte antigen mismatching, and unrelated cord blood donors. We have many well-established full and mini-transplant protocols so nearly any patient can receive a transplant.
“Many centers across the country are finding that outcomes of transplants using haploidentical or cord blood donors are very similar to matched donors,” O’Donnell says. “The incidence of acute or chronic graft-versus-host disease is surprisingly lower than or similar to matched donors using current protocols.”
The key to success for haploidentical transplants is the administration of high-dose cyclophosphamide after the transplant, “which is counter-intuitive,” says O’Donnell. The drug is given on days three and four post-transplant, and is followed on day five with standard immunosuppressive treatments. “The cost of this drug is only about $300,” says O’Donnell. “It’s a wonderfully low-tech approach in our high-tech era.”
This donor option was formerly restricted to pediatric patients. Now, SCCA physicians routinely use a combination of two cord blood units to extend the option to adults. “New studies in which one of the cord blood units is grown in the lab pre-transplant have been successful in increasing the rate of engraftment post-transplant,” O’Donnell says.
Examples of alternative donor protocols include:
Non-myeloablative HCT for Hematologic Malignancies Using Related, HLA-Haploidentical Donors (FHCRC-2372) A Phase II trial of peripheral blood stem cells (PBSC) as the donor source. Investigator: Paul O’Donnell, MD, PhD
Hematopoietic Bone Marrow Transplantation for Patients with High-risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome Using Related HLA-Mismatched Donors (FHCRC-2186) A trial using radiolabeled anti- CD45 antibody combined with immunosuppression before and after transplantation. Investigator: John Pagel, MD, PhD
Unrelated Donor Cord Blood Transplant with Reduced-intensity Preparative Regimen (FHCRC-2239) For patients who have leukemia, lymphoma, multiple myeloma, plasma cell neoplasm, myelodysplastic syndromes, or myelodysplastic/myeloproliferative diseases. Investigator: Colleen Delaney, MD, MSc
To enroll your patients in these trials, go to our Clinical Trials Database at www.seattlecca.org/clinical-trials.
Paul O’Donnell, MD, PhD is the medical director of the Adult Blood and Marrow Transplant Service at Seattle Cancer Care Alliance and clinical investigator in the Clinical Research Division of Fred Hutchinson Cancer Research Center, where he is working on leading-edge research using alternative donors for bone marrow transplantation.
In the past several years, his research has focused on allogeneic hematopoietic cell transplantation (HCT) from family donors (parents, siblings, and children) who are only partially matched (haploidentical). Very promising results that emerged from this clinical research led to a national study at 16 centers through the Blood and Marrow Transplant Clinical Trials Network.
“We are one of the few centers offering HCT options to any medically suitable patient for whom a transplant is indicated,” says O’Donnell. “We can find a donor for anybody who comes here … Transplant options are not limited by finding a matched, related donor.”
O’Donnell earned a graduate degree at Cornell University. After a 20-year career as a research scientist at Memorial-Sloan Kettering Cancer Center in New York, he completed medical school and an internship, residency, and oncology fellowship at Johns Hopkins University School of Medicine in Baltimore.
The SCCA Network Research Office has been informed that GlaxoSmithKline’s COMPLETE study (EGF 108919) may extend its accrual period from June 15, 2011 to September 1, 2011.
The COMPLETE trial is our first attempt to evaluate the effectiveness of offering pharmaceutical company studies to Network Member institutions. To be successful, we need your help to identify potential participants.
In late January, Network Member principal investigators were sent the results of three Phase III studies evaluating the efficacy of lapatinib in breast cancer that were presented at the 33rd Annual Meeting of the San Antonio Breast Cancer Symposium in 2010.
The results of these studies were reviewed by the COMPLETE Steering Committee which concluded that the COMPLETE trial continues to provide important clinical and biological information for patients with HER2/neu-positive, metastatic breast cancer especially as the correlative aspect of the study may shed light on the optimal treatment for specific types of HER2-positive cancers. Copies of the details from the reports are available from the SCCA Network Office by calling (888) 201-0060.
These are the studies that GlaxoSmithKlein are extending.
Study #1 (SABCS Poster #P3-14-24) Overall Survival Benefit Observed with Lapatinib Plus Paclitaxel as First-line Therapy in Patients with HER-2-Overexpressing Metastatic Breast Cancer
Randomization to lapatinib 1500 mg daily plus paclitaxel 80 mg/m2/week for 3 out of 4 weeks or to single agent paclitaxel 80 mg/m2/week for 3 out of 4 weeks with matching placebo. Paclitaxel was administered for 6 cycles. Lapatinib was administered until disease progression.
Primary endpoint was overall survival which was significantly improved in the lapatinib plus paclitaxel arm compared to the paclitaxel alone arm with median survival 27.8 vs. 20.5 months respectively (p=0.0005).
Most frequent adverse events were diarrhea (L+P 77%, grade 3/4 20/0; P alone 29%, grade 3/4. <1/<1) and neutropenia (L+P 77%, grade 3/4, 35/16; P alone 47%, grade 3/4, 15/5).
Study #2 (SABCS Oral Presentation at Session S3-1) Lapatinib versus Trastuzumab in Compbination with Neoadjuvant Athracycline-Taxane Based Chemotherapy (GEPARQUINTO STUDY – GBG 44)
Phase III study evaluating two separate questions: (1) the efficacy of lapatinib versus trastuzumab in patients with HER2/ neu-positive breast cancer and (2) the efficacy of bevacizumab in HER2/neu-negative breast cancer.
Patients with HER2/neu-positive breast cancer were randomized to EC 90/600 mg/ m2 q3w x 4 cycles followed by docetaxel 100 q3w x 4 cycles in combination with standard dosing trastuzumab q3w or lapatinib 1250 mg daily.
Primary endpoint was pCR defined as no invasive or in situ carcinoma in the breast or lymph nodes. In the EC -Doc + trastuzumab arm the pCR rate was 31.3% compared to 21.75% in the EC-Doc + lapatinib arm (p<0.5).
Diarrhea and neutropenia were frequent in the lapatinib arm leading to the mandatory use of GCSF in the lapatinib docetaxel portion of the regimen and a decrease in lapatinib dose to 10000 mg daily.
Study #3 (SABCS Oral Presentation at Session S3-3) First Results of the NeoALLTO (BIG 01-06/EGF106903): A Phase III Randomized Open Label, Neoadjuvant Study of Lapatinib, Trastuzumab and Their Combination Plus Paclitaxel in Women with HER2-Positive Primary Breast Cancer
Randomized neoadjuvant study comparing the efficacy of lapatinib versus trastuzumab versus their combination with taxane-based therapy. Standard dosing was used for paclitaxel and trastuzuamab. Following surgery all patients were treated with 3 cycles of anthracycline-based chemotherapy followed by an additional 34 weeks of targeted therapy.
Primary endpoint was pCR rate defined as absence of invasive breast cancer in the breast specimen. The pCR rates were significantly better in the combination lapatinib/trastuzumab arm compared to the trastuzumab arm; 51.3 versus 29.5 (p=0.0001). There was no stasticially significant differenece between the trastuzumab and lapatinib arms with respect to pCR – 29.5% versus 24.7% respectively.
Grade 3 or greater neutropenia and diarrhea were most common in the lapatinib containing arms compared to the trastuzumab arm.
MultiCare Regional Cancer Center established a body radiosurgery program in 2008 that received a very positive response from patients and referring physicians. The center’s staff strives to improve the service and has identified technological improvements that allow for a more precise and effective method of performing radiosurgery.
In October 2010, MultiCare successfully launched the CyberKnife robotic radiosurgery system that adapts to moving targets, like movement caused by breathing. It delivers treatment with a high level of precision, and is the only machine that is solely designed for and dedicated to body radiosurgery.
MultiCare Regional Cancer Center has treated more than 35 patients using the CyberKnife and has started a research program associated with it. All patients have the opportunity to participate in a multi-institutional prospective registry of CyberKnife patients that allows for independent data collection of treatment parameters and outcomes.
MultiCare is unique in its multi-platform approach to radiosurgery. To match the needs of individuals, MultiCare physicians and patients have the ability to choose from a wide range of approaches, including the
Trilogy linear accelerator-based radiosurgery program, volumetric-modulated arc-based therapy (RapidArc), the Brainlab guidance system, and the stereotactic robotic radiosurgery system (CyberKnife).
MultiCare is recruiting for multi-institutional prospective trials for early stage prostate cancer, Stage I lung cancer, medically inoperable, and oligometastatic disease of the liver.
To learn more, visit www.multicare.org.
Jasmine T. Daniels, MD is a board-certified hematologist, oncologist, and internal medicine specialist. She cares for patients who require treatment for a wide range of cancers and hematologic disorders.
“My goal as a physician is excellent patient care, emphasizing compassion and communication, and always involving the patient in the decision-making process,” says Daniels, who earned her medical degree from the F. Edward Hébert School of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. She went on to complete her internship and residency in internal medicine at the Walter Reed Army Medical Center. Daniels remained at Walter Reed for her fellowship in hematology-oncology.
Daniels is a fellow and active member of the American College of Physicians and the American Society of Clinical Oncology. Passionate about clinical research, she has served as the Principal Investigator of the Southwest Oncology Group (SWOG) at Madigan Army Medical Center (MAMC) and has collaborated on protocols and publications with investigators at Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance. Daniels is also an assistant professor at the Uniformed Services University of the Health Sciences. In her spare time, she enjoys cooking, watching movies, skiing, and traveling.
Providence Alaska Medical Center has been a Seattle Cancer Care Alliance Network member since 2008, but Providence has served Alaskans for much longer. The Sisters of Providence arrived in Nome in 1902, during the Alaska Gold Rush. Their pioneering spirit set the standard for health care in Alaska and formed the foundation for Providence’s growth as the state’s leading health care provider.
Today, Providence serves Anchorage, Matanuska-Susitna Valley, Kodiak Island,
Seward, and Valdez. Services offered range from inpatient care, including a heart and vascular center, The Children’s Hospital at Providence, surgery centers, orthopedic services, imaging, laboratory, and other ancillary services. Providence also offers specialty clinics, long-term care, and assisted living facilities. More than 4,000 employees work for Providence. They are committed to serving patients’ needs by providing the highest quality care through compassionate health care services.
In 2008, Providence opened the Cancer Center offering state-of-the-art services with a holistic, team approach toward healing. The 45,000 square-foot center provides outstanding clinical services along with specialized programs such as genetics counseling, appearance support, patient navigators, healing arts, and a resource center for community education accessible to all Alaskans regardless of where they are receiving care. The Cancer Center also includes the latest in radiation oncology, an infusion center, oncology rehabilitation, a family center, and hospice and palliative care.
To learn more, visit www.providence.org/alaska.
Joanie Mayer Hope, MD, is a gynecologic oncologist with Denali OB-GYN Clinic and the director of Gynecologic Oncology at Providence Alaska Medical Center’s Cancer Center in Anchorage.
The only gynecologic oncologist practicing in Alaska, Hope has a special interest in emerging technologies to promote early cancer detection, such as contrast enhanced ultrasound. She is interested in addressing disparities in healthcare and helping meet the health needs of underserved populations.
Hope is also a lead singer for N.E.D.—No Evidence of Disease—a rock band whose six geographically scattered members are gynecologic oncologists. The band, which came together to raise awareness about women’s cancer issues, just released its second CD.
“This isn’t just a hobby for us,” says Hope. “It’s really a powerful interface of music and our work as gynecologic oncologists. It’s about our desire to bring greater awareness to these cancers and the need for more research and better treatments.”
Hope earned her bachelor’s degree from Stanford University. She earned her medical degree at State University of New York. She completed an obstetrics-gynecology residency followed by a gynecology oncology fellowship at New York University. When she’s not working, Hope enjoys spending time with her daughter. She’s also an avid athlete who enjoys running, mountain biking, skiing, and other outdoor activities.
Adolescents and young adults with cancer have unique needs and treatment challenges—many of which fall in the gap between programs designed for children and those for adults. It often takes longer to get a diagnosis and treatment, possibly due to the perception of physicians and the patients themselves that they belong to a healthy population.
Teens and young adults are much less likely than children to get the most advanced treatments by taking part in clinical trials, which may contribute to the fact that cancer survival rates for teens and young adults have not improved since the 1970s.
Seattle Children’s, an SCCA parent organization, is eager to work with physicians to improve care for young people. Through the Adolescents and Young Adults Oncology Program, Children’s seeks to give expert medical care and support to cancer patients in their teens and 20s. “We want to work together with medical oncology physicians to provide these patients with the best care possible,” says Becky Johnson, MD, medical director of the program since 2007.
Recent data shows that, for certain kinds of leukemia and sarcoma, teens and young adults have better results when treated on pediatric programs or at pediatric hospitals. For example, Johnson says, patients in their teens and 20s with acute lymphoblastic leukemia who are treated on pediatric protocols have a 25 percent increase in long-term survival. Patients with Ewing’s sarcoma treated at a pediatric hospital had a more than 20 percent improvement in survival compared to those receiving the same therapy on an adult protocol.
“This shows that the treatment protocol and location of care have the potential to dramatically affect cancer treatment outcomes in teens and young adults,” says Johnson.
The Adolescents and Young Adults Program offers an expanding network of facilities. Patients can receive the most intensive parts of their therapy at Seattle Children’s, and then continue their care at SCCA Network sites.
A key benefit of the program is its ability to provide patients with access to the most advanced protocols available. These include clinical trials at Seattle Children’s and the Fred Hutchinson Cancer Research Center.
The Seattle Children’s Adolescents and Young Adults Oncology Program specializes in fertility preservation consultations and referrals. Specialists also provide consultation on treatment options for patients seeking care at Seattle Children’s or elsewhere in the community. The program emphasizes a team approach to care, providing support from experts in psychiatry and behavioral medicine, social work, palliative care, and child life services designed specifically for teens and young adults.
For more information, call (866) 987-2000.
In 2006, an estimated 11.4 million cancer survivors were living in the United States. That number is expected to increase to nearly 20 million by 2020.
With survivorship recognized as a distinct phase of care in the cancer continuum, the focus in cancer care turns to surveillance for and management of long-term and late effects that occur as a result of cancer and its treatment, as well as routine health promotion and prevention of disease.
In 2006, the Institute of Medicine (IOM) published an influential report, From Cancer Patient to Cancer Survivor: Lost in Transition. The report examined a broad range of medical and psychosocial issues faced by cancer survivors as a consequence of their disease and its treatment. The IOM report recommended that patients who are completing primary treatment receive a comprehensive care summary and follow-up care plan that is clearly and effectively explained. This “survivorship care plan” summarizes critical information needed for the survivor’s long-term care. It includes:
- Cancer type, treatments received, and their potential consequences
- Specific information about the timing and recommended follow-up
- Recommendations regarding preventive practices and how to maintain health and well-being.
The Survivorship Program at Fred Hutchinson Cancer Research Center and SCCA is developing a web-based survivorship application that will serve the clinical needs of the SCCA Network. Each participating SCCA Network member will have access to the survivorship application and can enroll its patients online. Providers can enter each patient’s demographic, diagnostic, and treatment data. This information will make up a survivor treatment summary.
The survivorship application includes algorithms that provide risk-based recommendations for a patient’s treatment based on disease-specific guidelines from the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and best practices developed locally. Together, the recommendations constitute the patient’s survivorship care plan. The plans will be given to cancer survivors, their oncologists, and their primary care physicians.
The Survivorship Care Plan is designed to inform clinicians involved in the care of cancer survivors of treatment exposures, signs and symptoms of late effects, and recommended care for the future. A secondary aim of the survivorship application is to gather data on cancer treatment exposures and long-term and late effects which will support the development of cancer-related guidelines for follow-up of adult cancer survivors.
The database will be available to Network Members this summer.
SCCA Network members Overlake Hospital Medical Center and Skagit Valley Hospital received accreditation by the National Accreditation Program for Breast Centers (NAPBC) in 2011.
The NAPBC is a consortium of national organizations dedicated to improving quality of care and monitoring outcomes for patients with breast diseases. To be accredited, breast centers undergo rigorous review and must demonstrate that they offer a multidisciplinary team approach to coordinate care, provide access to breast cancer-related information and support, and breast cancer data collection on quality indicators for all subspecialties involved in breast cancer diagnosis and treatment.
In addition, breast centers must perform ongoing monitoring of care improvement and provide patients with information about clinical trials and new treatment options.
“The breast cancer program at Overlake received full accreditation from the NAPBC, an independent review board. We are the first center in the greater Seattle area to receive the accreditation,” says breast surgeon and Overlake Breast Health Team Chair Kristi Harrington, MD, PhD. “Our patients can be confident that they are receiving the highest caliber multidisciplinary evaluation and treatment available when they choose to have their breast health care at Overlake.”
“The Breast Institute at Skagit Valley Hospital provides a patient-centered, multidisciplinary approach to the diagnosis and treatment of breast cancer at all stages,” says Theodore Kim, MD, Skagit Valley Hospital Breast Institute medical director. “Our recent full three-year accreditation by the NAPBC is an endorsement that we provide the highest quality of care for the patients in our community.”
From Network Newsletter December 2010 Issue Correction: There were several typographical errors in the article “Network in the Community.” We said, “Olympic Medical Center’s Eight Annual Harvest of Hope Gala took place on October 23rd. A fabulous four-course dinner was prepared by Chef Doug Seaver of Michale’s Divine Dining in Port Angeles and paired with featured wines. The gala supports patients and families of the Thomas Family Center at the Olympic Medical Center.”
It should have read, “Olympic Medical Center’s Eighth Annual Harvest of Hope Gala took place on October 23rd. A fabulous four-course dinner was prepared by Chef Doug Seaver of Michael’s Divine Dining in Port Angeles and paired with featured wines. The gala supports patients receiving care at the Thomas Family Cancer Center at Olympic Medical Center, and their families.”